Important Safety Information

Indications, Contraindications, Warnings and Precautions

All Medtronic MiniMed devices and associated components listed below are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems.

Patients should always discuss potential risks and benefits with a physician. Please review the product manual prior to use for detailed instructions and disclosure.

Warnings/Precautions

Insulin pump therapy uses only rapid-acting U100 insulin. Therefore, any interruption in insulin delivery (due to infusion set clogs, leaks, loss of insulin potency, or pump malfunction) may result in hyperglycemia (high blood glucose) within 2-to-4 hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within 4-to-10 hours. The onset of stress or illness (caused by infection or an emotional event) can also result in a rise of blood glucose levels and the development of DKA.

Establish a plan with your healthcare professional for rapidly identifying and treating both hypoglycemia and hyperglycemia, to prevent the onset of DKA and possible hospitalization. Act quickly to respond to out-of-target blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of high blood glucose, or of an increased frequency in low or high blood glucose.

If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately. Always carry an "emergency kit" of supplies that includes insulin, syringes or pens, blood glucose test strips and meter and urine ketone test strips, in case you develop a problem with your pump and your insulin delivery is stopped, or in case of high blood glucose. You should check for urine or blood ketones whenever your blood glucose is elevated above 250 mg/dL (13.7 mmol/L) and take an insulin injection if appropriate. For proper infusion set insertion techniques, follow the advice of your healthcare professional and the Instructions for Use included with the product. Change your infusion site every 2-to-3 days, according to your healthcare professional's suggestions, and according to the Instructions for Use that accompany the infusion sets and reservoirs. Check the amount of insulin remaining in your reservoir at least once a day. Infection at the infusion site is a risk of pump therapy. Check the infusion site often for redness, irritation and inflammation.

Bolus Wizard Feature

If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to correctly determine the active insulin in your system. Consult with your healthcare professional on how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard feature.

Use only the reservoir and infusion sets specifically designed for your pump. Use of non-Medtronic MiniMed reservoirs and/or infusion sets may interfere with proper pump operation. Do not modify your reservoir or infusion set.

Tubing Connector

If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the reservoir from the transfer guard. If you do not hold the insulin vial upright, insulin can get on the top of the reservoir and could transfer liquid into the tubing connector. If any liquid gets on the top of the reservoir or inside the tubing connector when you change your infusion set, start over with a new reservoir and infusion set.

If you are going to have an X-ray, CT scan, MRI or any other type of radiation therapy, take your pump and remote control off, and remove them from the treatment area.

The pump is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.

Do not use any lubricants on the pump mechanism. Do not use hot air to dry your pump. This may damage your pump's internal electronics.

Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential; therefore, that you test your blood glucose levels at least four times per day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered.

MiniMed® 670G System

The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G System includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed 670G System consists of the following devices: MiniMed 670G Insulin Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-press Serter, and the CONTOUR NEXT Link 2.4 Glucose Meter. The system requires a prescription.

The Guardian Sensor (3) is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).

WARNING: Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional to treat low glucose. Using Suspend on low alone to prevent or treat low glucose may result in prolonged hypoglycemia.

WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.

WARNING: Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in the active insulin amount. Therefore, the Bolus Wizard could prompt you to deliver more insulin than needed. Too much insulin can cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard.

Guardian Sensor (3)
The Guardian Sensor (3) is intended for use with the MiniMed 670G system to continuously monitor glucose levels in persons with diabetes. It is intended to be used for detecting trends and tracking patterns in persons aged fourteen years and older, and to be used by the MiniMed 670G system to automatically adjust basal insulin levels. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. The Guardian Sensor (3) is indicated for 7 days of continuous use.

One-press Serter
The serter is used as an aid for inserting the sensor. It is indicated for single-patient use and is not intended for multiple patient use.

Guardian Link (3) Transmitter
The Guardian Link (3) Transmitter is intended for use with MiniMed 670G System.
The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 670G insulin pump. The Transmitter is intended for single-patient multi-use.

CONTOUR®NEXT LINK 2.4 Glucose Meter
The CONTOUR®NEXT LINK 2.4 Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single patient use only and should not be shared. The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR®NEXT LINK 2.4 wireless blood glucose transmit glucose values to the MiniMed 670G insulin pump and facilitate transfer of information to Medtronic CareLink® Software through the use of radio frequency communication. The
CONTOUR®NEXT LINK 2.4 Wireless Blood Glucose Monitoring System is not intended for the diagnosis of, or screening for, diabetes mellitus. It is not intended for use on neonates.

Contraindications
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Do not use the serter on products other than the Enlite sensor or Guardian Sensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other products. The reservoir is contraindicated for the infusion of blood or blood products.
Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Insulin pump therapy is not recommended for those who are unwilling to perform at least four blood glucose tests per day. As insulin pumps use rapid acting insulin only, BG testing is required to help identify rapid glycemic deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

MiniMed®630G System with SmartGuard™ Technology

The MiniMed 630G system with SmartGuard technology is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 630G system includes SmartGuard technology, which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed 630G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 630G system.

The MiniMed 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the SmartGuard technology Suspend on low alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

Warnings

WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. The Suspend on low feature is designed to suspend insulin delivery when you are unable to respond to the Suspend on low alarm. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional. Using Suspend on low to prevent or treat low glucose may result in prolonged hypoglycemia.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day.

Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

MiniMed® 530G System with SmartGuard™ Technology

Indications for Use

The MiniMed 530G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G system can be programmed to automatically suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed 530G system consists of the following devices that can be used in combination or individually: MiniMed 530G insulin pump, Enlite® sensor, Enlite® serter, the MiniLink® Real-Time transmitter, Bayer’s CONTOUR® NEXT LINK wireless meter, CareLink® Pro therapy management software for diabetes, and CareLink® Personal therapy management software for diabetes. The system requires a prescription.

The MiniMed 530G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 530G system. The MiniMed 530G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the Threshold Suspend alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

Warning

WARNING: The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the Getting Started Guide and the MiniMed 530G System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day.

Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

MiniMed Paradigm® REAL-Time Revel™ Insulin Pump

The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm REAL-Time Revel system consists of the Paradigm MMT-523/MMT-723 insulin pumps, the Enlite glucose sensor (MMT-7008), and the MiniLink Transmitter (MMT-7703). Use of the Paradigm MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).

Enlite Sensor

The Enlite sensor (MMT-7008) is intended for use with the Paradigm REAL-Time Revel insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm REAL-Time Revel system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm REAL-Time Revel system.

Meter

The Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted from Bayer's CONTOUR® NEXT LINK Wireless Meter for use in the Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump. For additional details, including warnings, precautions, and contraindications, please consult the product user guide at http://www.medtronicdiabetes.com/download-library/minimed-revel.

CareLink® Personal Therapy Management Software

Indications for Use

The CareLink software is intended for use as a tool to help manage diabetes. The purpose of the software is to take information transmitted from insulin pumps, glucose meters and continuous glucose monitoring systems, and turn it into CareLink reports. The reports provide information that can be used to identify trends and track daily activities-such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. There are two versions of Medtronic MiniMed CareLink Therapy Management Software available - CareLink Personal and CareLink Pro.

Contraindications

The CareLink software should not be used for the treatment of medical conditions other than diabetes.

Warnings/Precautions

The software is intended to be used by or with advice from a healthcare professional familiar with the management of diabetes.

System results are not intended to produce medical advice and should not be relied upon for such purpose.

Patients should monitor their blood glucose levels at least 4 - 6 times a day.

Patients should not make any changes to their treatment without consulting their healthcare professional first.

Indications for Use

The CGMS iPro Digital Recorder or CGMS Gold is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the CGMS iPro Digital Recorder or CGMS Gold may be downloaded and displayed on a computer and reviewed by healthcare professionals. This information may allow identification of patterns of glucose-level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.

The CGMS iPro Digital Recorder or CGMS Gold:

Will not allow readings to be made available directly to patients in real time.

Provides readings that will be available for review by physicians after the recording interval (72 hours).

Is currently intended for occasional rather than everyday use.

Is not intended to change patient management based on the numbers generated, but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take fingerstick glucose measurements to better manage the patient.

Contraindications

Do not use magnetic mattress pads while wearing the CGMS iPro Digital Recorder. The magnetic mattress pad will cause the digital recorder to frequently enter a transmission mode that will quickly drain the rechargeable battery and will temporarily disable data collection. Therefore, there will be sensor data gaps and the digital recorder is likely to not function for the entire 3-day duration. The magnetic mattress pad will not, however, affect the accuracy of the sensor readings that are collected, nor will it lead to any unsafe conditions.

Do not expose your digital recorder to MRI equipment or other devices that generate strong magnetic fields. If your digital recorder is inadvertently exposed to a strong magnetic field, discontinue use and contact your physician.

Successful operation of the CGMS System Gold requires some visual and auditory acuity. Use of the CGMS System Gold is not recommended for patients whose impaired vision or hearing does not allow full recognition of the Monitor signals and alarms, or who do not have a caregiver that can perform this function for them.

Warnings/Precautions

Product contains small parts and may pose a choking hazard for young children.

Do not place the CGMS iPro Magnetic Wand or any other magnet within 1.5 inches (3.8cm) of the CGMS iPro Digital Recorder except while performing patient set-up and data download procedures. Premature battery discharge may occur.

Do not insert the glucose sensor with attached CGMS iPro Digital Recorder closer than two to three inches (5.08 - 7.62 cm) from the insulin pump. The use of the CGMS iPro Magnetic Wand may inadvertently cause incorrect operation of the pump.

If performing multiple CGMS iPro Digital Recorder studies on the same patient, establish a rotation schedule for choosing new glucose sensor sites. Avoid sites that are constrained by clothing, have scar tissue, or are subject to rigorous movement during exercise.

If any blood gets inside the CGMS iPro Digital Recorder connector, the CGMS iPro Digital Recorder must be discarded.

CGMS System Gold users should be educated to program and operate the Monitor and respond to alarm conditions prior to attempted use of the system.

Using the CGMS Gold Monitor in close proximity to strong electromagnetic sources, such as medical imaging equipment, television and radio transmitters and high-voltage power lines, is not recommended.

The current and voltage signals shown in the CGMS Gold Monitor are to be used only for finding potential problems with the CGMS System Gold and do not indicate the current glucose value.

The REAL-Time CGM System consists of the Guardian REAL-Time Continuous Glucose Monitor or MiniMed Paradigm REAL-Time (Revel) Pump, as well as separately available glucose sensor and MiniLink REAL-Time transmitter.

Indications for Use

The REAL-Time CGM Device, with the separately available glucose sensor and transmitter, are indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (age 18 or older).

Information provided by the REAL-Time CGM devices is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. Glucose values provided by the REAL-Time CGM device are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the REAL-Time CGM devices.

The MiniLink REAL-Time transmitter is indicated for use as a component of select Medtronic continuous glucose sensing systems and Medtronic MiniMed sensor-enabled pump systems.

Contraindications

Glucose monitoring therapy is not recommended for people who are unwilling or unable to perform a minimum of four meter blood glucose tests per day and to maintain contact with their healthcare professional. Use of a glucose monitoring system and requires sufficient vision or hearing to allow recognition of the monitor signals and alarms.

Do not expose your MiniLink REAL-Time transmitter to MRI equipment or other devices that generate strong magnetic fields. If your MiniLink Real-Time transmitter is inadvertently exposed to a strong magnetic field, discontinue use and contact your physician.

Warnings/Precautions

Although the CGM device has multiple safety alarms, it cannot tell you about all potential problems. You must test your blood glucose levels at least two times per day. Check your blood glucose using your blood glucose meter before making any therapy changes.

Blood glucose measurements taken when your glucose levels change rapidly should not be used to calibrate your system.

Product contains small parts and may pose a choking hazard for young children. Do not use the MiniLink Real-Time transmitter to send glucose readings to the monitor while onboard an aircraft. Disconnect the MiniLink REAL-Time transmitter from the sensor while travelling on an aircraft or if interference with other transmitting devices occurs.

iPro®2 Professional Continuous Glucose Monitoring (CGM)

The iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the iPro2 digital recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals. The information may allow identification of patterns of glucose-level excursions above and below a desired range, facilitating therapy adjustments, which may minimize these excursions.

The iPro2 system is intended for prescription use only.

Does not allow data to me made available directly to patients in real time

Provides data that will be available for review by physicians after the recording interval (up to72 hours for Sof-sensor glucose sensor; 144 hours for Enlite sensor)

Is intended for occasional rather than everyday use

Is to be only used as a supplement to, not a replacement for, standard invasive measurement

MiniMed® Sof-sensor® Glucose Sensor

The glucose sensor (Sof-sensor) can be used either with a REAL-Time CGM System, or with a Professional CGM System.

Please refer to Medtronic MiniMed REAL-Time CGM System, or Medtronic MiniMed Professional CGM System sections for important safety information regarding the REAL-Time CGM System (including MiniLink REAL-Time Transmitter) and Professional CGM System, respectively.

Indications for Use

The Sof-sensor glucose sensor is intended for use with Medtronic MiniMed glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Warnings/Precautions

Failure to follow instructions may result in pain or injury.

Bleeding, swelling, irritation or infection at the insertion site are possible risks associated with inserting the sensor and may result from improper insertion and maintenance of insertion site.

After insertion, wait 5 minutes before attaching the transmitter to watch for bleeding at the insertion site. If bleeding occurs, apply steady pressure using a sterile gauze or clean cloth for up to 3 minutes.

If bleeding stops:

Attach the sensor to the transmitter.

If bleeding does NOT stop:

CAUTION: DO NOT attach the sensor to the transmitter.

Remove the sensor and discard.

Check the site for redness, bleeding, irritation, pain, tenderness or inflammation and treat accordingly.

Insert a new sensor in a different location.

The sensor is sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use any glucose sensor if its sterile package has been previously opened or damaged. Always inspect packaging for damage prior to use.

If sensor is not securely placed in Sen-serter® prior to insertion, pain or minor injury may occur.

Remove needle guard before inserting sensor. If you develop inflammation, redness, soreness or tenderness at insertion site, or if you experience unexplained fevers, remove sensor. Check site often for these conditions and to ensure sensor is still in place, especially before going to bed and upon waking.

For single patient, one time use only. Reuse of the sensor may cause damage to the sensor surface, and lead to inaccurate glucose values, site irritation and/or infection.

Enlite® Sensor

Indications for Use

The sensor is intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

Contraindications

None known

General Warnings

Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is high or low, or if you feel symptoms of high or low glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe high or low glucose conditions.

Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.

Keep the needle housing within sight at all times to avoid accidental needle stick injury.

Always inspect the packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Watch for bleeding at the insertion site (under, around, or on top of the sensor). Apply steady pressure using sterile gauze or a clean cloth placed on top of the sensor for up to three minutes, if bleeding occurs. The use of unsterile gauze can cause an infection.

Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter’s connector, which can damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.

Remove the sensor and discard.

Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.

Insert a new sensor in a different location.

Keep the sensor away from children. This product contains small parts and may pose a choking hazard.

General Precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.

Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.

Do not insert the sensor through tape to ensure proper sensor function and insertion.

Only use alcohol to prepare the insertion site to ensure that residue is not left on the skin.

Rotate the sensor insertion site so that sites do not become overused.

Discard used sensors and needle housings in a sharps container after each use to avoid accidental needle stick injury.

Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needle stick may occur.

Do not reuse sensors. Reuse of the sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection

One-press Serter

Indications for Use

The serter is used as an aid for inserting the Enlite sensor. It is indicated for single-patient use and is not intended for multiple patient use.

Contraindications

Do not use the serter on products other than the Enlite sensor. Medtronic cannot guarantee the safety or efficacy of this product if used with other products.

General warnings

Read this entire user guide before attempting to insert the sensor. The serter does not work the same as other Medtronic insertion devices. Failure to follow directions may result in improper insertion, pain, or injury.

Contact the 24-hour helpline or your local representative, if you have questions or concerns. Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, do the following prior to making therapy decisions. Confirm your blood glucose with your BG meter using a fingerstick blood sample.

A retractable needle is attached to the sensor and minimal blood splatter may occur. If you are a healthcare professional or caregiver, wrap sterile gauze around the sensor to minimize contact with blood. Keep as much distance as possible between you and the patient when removing the needle.

Keep the needle housing within sight at all times to avoid an accidental needlestick or puncture.

Always inspect the sensor packaging for damage before use. Sensors are sterile and non-pyrogenic, unless the package has been opened or damaged. Do not use the sensor if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Watch for bleeding at the insertion site (under, around, or on top of the sensor).

If bleeding occurs, do the following:

Apply steady pressure using sterile gauze or a clean cloth, placed on top of the sensor for up to three minutes. The use of unsterile gauze can cause site infection.

If bleeding stops, connect the transmitter to the sensor. If bleeding does not stop, do not connect the transmitter to the sensor because blood can get into the transmitter connector, and could damage the device.

If bleeding continues, do the following:

Remove the sensor and continue to apply steady pressure until the bleeding stops. Discard the sensor in a sharps container.

Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation. Treat based on instructions from your healthcare professional.

Insert a new sensor in a different location.

Make sure the sensor is securely placed in the serter to avoid improper insertion, pain, or minor injury.

Keep the serter away from children. This product contains small parts and may pose a choking hazard.

General Precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.

If you are a healthcare professional or caregiver, wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.

Do not insert the sensor through tape. Inserting the sensor through tape may cause improper sensor insertion and function.

Only use alcohol to prepare the insertion site, to ensure that residue is not left on the skin.

Rotate the sensor insertion sites so that they do not become overused.

Discard used sensors and needle housings in a sharps container after each use to avoid accidental needlestick or puncture.

Do not clean, resterilize, or try to extract the needle from the needle housing. An accidental needlestick or puncture may occur.

Do not reuse sensors. Reuse of a sensor may cause damage to the sensor surface and lead to inaccurate glucose values, site irritation, or infection.

Always make sure the sensor is firmly attached so that it does not come out of your body. Factors that may increase the likelihood of the sensor falling off include increased physical activity (particularly for younger patients) and improper taping technique.

Enlite® Serter

Indications for use

The Enlite serter is indicated for use for a single patient as an aid to insert the Enlite glucose sensor (sensor).

Contraindications

Do not use the Enlite serter on products other than the Enlite sensor. Medtronic cannot guarantee this product’s safety or efficacy if used on other products.

General warnings

Read this entire user guide before attempting to insert the sensor. The Enlite serter does not work the same as other Medtronic insertion devices. The serter injects the sensor into the insertion site when the button is released, not when the button is pressed.

Failure to follow directions may result in pain or injury.

Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe low or high glucose conditions.

Keep an arm’s length between you and the patient when removing the needle. A retractable needle is attached to the sensor and minimal blood splatter may occur.

Keep the needle housing within sight at all times to avoid accidental needle stick injury.

Always inspect the sensor packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless the package has been opened or damaged. Do not use any of the sensors if the sterile package has been opened or damaged. Use of an unsterile sensor can cause site infection.

Watch for bleeding at the insertion site (under, around, or on top of the sensor). Apply steady pressure using sterile gauze or a clean cloth placed on top of the sensor for up to three minutes, if bleeding occurs. The use of unsterile gauze can cause an infection.

Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter connector, which may damage the device. Remove the sensor and continue to apply steady pressure until the bleeding stops.

Remove the sensor and discard in a sharps container.

Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.

Insert a new sensor in a different location.

Make sure the sensor is securely placed in the serter to avoid pain or minor injury.

Keep the serter away from children. This product contains small parts and may pose a choking hazard.

CONTOUR®NEXT LINK 2.4 meter

Indications for Use:

The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The system consists of a CONTOUR®NEXT LINK 2.4 wireless blood glucose meter, CONTOUR®NEXT test strips and CONTOUR®NEXT control solutions.

CONTOUR®NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system is intended to be used to transmit glucose values to MiniMed® 630G Pump and facilitate transfer of information to Medtronic CareLink® Software through use of radio frequency communication.

The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Warnings/Precautions:

Meter

Do not calibrate your continuous glucose monitoring device from an Alternative Site Testing (AST) or control solution test result.

Do not calculate a bolus based on an AST or control solution test result.

Do not send an out of range control solution test result to your pump. If the control solution test result is out of range, the result may be transmitted to your pump when in “Always” send mode.

Always check the display on your pump to ensure that the glucose result shown agrees with the glucose result shown on the meter.

General Warnings:

Meter

Serious Illness

Capillary (fingerstick or Alternative Site) blood glucose testing may not be clinically appropriate when peripheral flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia, diabetic ketoacidosis, and occurrence of severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.1,2,3

Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed.

If your blood sugar reading is over 250 mg/dL, wash and dry your hands well and repeat the test with a new strip. If you get a similar result, call your health care professional as soon as possible.

About whether Alternative Site Testing (AST) is appropriate for you.

Potential Biohazard

Always wash and dry your hands well with soap and water before and after testing, handling the meter, lancing device or test strips.

The meter, lancing device and lancets are for single person use. Do not share them with anyone including other family members. Do not use on multiple persons.4,5

All parts of this kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. For Cleaning and Disinfection instructions, please refer to the meter’s user guide.

The lancing device provided by Ascensia Diabetes Care is intended for self-testing by a single patient. It must not be used on more than one person due to the risk of infection.

Use a new lancet each time you test because it is no longer sterile after use.

Always dispose of test strips and lancets as medical waste or as advised by your health care professional. All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

Precautions:

Please follow all instructions for use and care exactly as described to help avoid inaccurate results.

Examine product for missing, damaged, or broken parts. If the test strip bottle is open inside a new box of strips, do not use those strips. For replacement parts, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.

The CONTOUR®NEXT LINK 2.4 meter from Ascensia Diabetes Care only works with CONTOUR®NEXT test strips and CONTOUR®NEXT control solutions.

Always keep the CONTOUR®NEXT test strips in their original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, and dirt. Exposure to room humidity from leaving the bottle open or not storing the strips in their original bottle can damage your test strips. This could lead to inaccurate results. Do not use a test strip that appears damaged or has been used.

Check the expiration dates on your test strips and control solution. Do not use the test strips or control solution if the expiration date printed on the bottle label and carton has passed. This can cause inaccurate results. For the control solution, do not use if it has been 6 months since you first opened the bottle. After first opening the bottle, write the 6-month discard date on the control solution label.

If your control solution test result is out of range, contact Ascensia Diabetes Care Customer Service at 1.800.848.8100. Do not use the meter for blood glucose testing until you resolve this issue.

The meter has been designed to give accurate results at temperatures between 41° to 113°F. If you are outside this range, you should not test. Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood glucose test.

Do not perform a blood glucose test when the CONTOUR®NEXT LINK 2.4 meter is connected to a computer.

Use only approved cables or wall charger from the manufacturer or a 5V charger approved by a certified body such as UL or TUV.

The CONTOUR®NEXT LINK 2.4 meter from Ascensia Diabetes Care has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter of blood).

Results in m g/dL will never have a decimal point;

Results in m mol/L will always have a decimal point.

Example: 93 mg/dL or 5.2 mmol/L

Check your display screen to be sure the results are shown the right way. If not, please contact Ascensia Diabetes Care Customer Service at 1.800.848.8100.

The CONTOUR®NEXT LINK 2.4 wireless blood glucose monitoring system from Ascensia Diabetes Care has a measuring range of 20 mg/dL to 600 mg/dL.

If your blood sugar reading is over 600 mg/dL the next screen will tell you to retest. The meter will beep twice. If results are still over 600 mg/dL, “Follow Medical Advice Immediately” is displayed.

Please be aware that USB ports in some computers and self-powered USB hubs can become much warmer than the room. A USB extension cable is available. If you wish to test immediately after disconnecting from your computer, please use the USB cable to protect the meter from exposure to heat created by the computer.

i-Port Advance® Injection Port

Indications for Use

i-Port Advance injection port is indicated for patients who administer or receive multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple injections without the discomfort of additional needle sticks. i-Port Advance injection port may be used on a wide range of patients, including adults and children.

Contraindications

Do not use the same i-Port Advance injection port for longer than 72 hours.

Do not attempt to reapply the i-Port Advance injection port after use.

The i-Port Advance injection port is neither intended nor indicated for use with blood or blood products.

Do not use the i-Port Advance injection port for any purpose other than the indications specified by your healthcare provider.

Do not use a needle longer than 5/16 in. (8 mm) or thicker than 28 gauge when injecting into the i-Port Advance injection port.

Warnings/Precautions

The i-Port Advance injection port is only sterile and nonpyrogenic if the insertion device is unopened or undamaged. Do not use if the package is already open or is damaged, or if the protective liner has fallen off. Ensure the sterility by checking the sterile paper and tamper-proof seal.

Carefully read through instructions prior to using the i-Port Advance injection port. Failure to follow instructions may result in pain or injury.

If the i-Port Advance injection port is not securely placed in the inserter with the needle pointing straight ahead prior to insertion, pain or injury may occur.

Be sure that the needle guard is removed before insertion.

Do not use if introducer needle is bent or broken.

Do not use a needle longer than 5/16 in. (8 mm). Do not attempt to use a 1/2 in. (12 mm) injection needle with the i-Port Advance injection port. Doing so may damage the device causing unnecessary punctures of the skin, or tearing or puncturing of the soft cannula which may result in unpredictable medication delivery.

Do not use a needle shorter than 3/16 in. (5 mm) when injecting into the i-Port Advance injection port.

Do not inject multiple drugs contraindicated for subcutaneous administration into the same site.

The i-Port Advance injection port is a single use device. Reuse of the port may damage the cannula in the device and increases the risk of the tape becoming loose. Reuse of the port may result in infection or site irritation and inaccurate medication delivery.

Incorrect medication absorption, infection, or site irritation may result from improper application to the body or maintenance of the i-Port Advance injection port insertion site, or both. If the insertion site becomes irritated or inflamed, remove and discard the device and apply a new device to a different location on the body.

The soft cannula may crimp or bend when applying or while wearing. A crimped or bent cannula may limit or prevent medication delivery through the i-Port Advance injection port. You should remove and discard the device immediately if you suspect a crimped or bent cannula. Indications that your i-Port Advance injection port has a crimped or bent cannula include:

difficulty pressing down on the plunger of the syringe when injecting

Injected medication escaping from the device onto the top of the septum

injected medication leaking onto the skin or saturating the tape

moisture present inside the transparent body of the device

Do not reinsert the introducer needle into the i-Port Advance injection port. Reinsertion could cause puncturing or tearing of the soft cannula which would result in unpredictable medication delivery or injury.

Replace the i-Port Advance injection port if the tape becomes loose or is displaced from its original site. Since the cannula is soft, it may not cause pain if it slips out, and this may occur without you noticing it. The soft cannula must always be completely inserted to receive the full amount of medication from the injection.

Wash your hands and swab skin with alcohol or similar disinfectant where you intend to apply the i-Port Advance injection port. Let skin surface dry completely prior to applying the device to the disinfected area.

Ensure the septum is clean before every use (use pure water).

Do not put perfumes or deodorants on the i-Port Advance injection port as these may affect the integrity of the device.

Do not inject into the i-Port Advance injection port through clothing.

Never point the loaded inserter toward any body part where insertion is not desired.

Store i-Port Advance at room temperature. Do not store or leave the device in direct sunlight.

Avoid applying the i-Port Advance injection port to sites that contain scar tissue, lipodystrophy, or stretch marks. Avoid sites that are constrained by clothing or accessories, or that are subjected to rigorous movement during exercise. Avoid sites that are under a belt or on the waistline.

Do not inject more than 75 times through a single device.

The device has a residual volume up to 2.60 μL (0.0026 mL or 0.26 units). It is not known if the residual drug remains in the cannula or is absorbed into the subcutaneous tissue over time. The prescribing healthcare provider should consider if the retention of, or delay in delivery of small doses of a drug (such as 1 international unit or 10 μL of U100 insulin) may adversely affect the therapeutic goals in some patients such as infants or small children.

MiniMed® Connect Mobile Accessory

Indications for Use

The MiniMed Connect mobile accessory is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or MiniMed Paradigm® REAL-Time RevelTM system for the purposes of passive monitoring.

The MiniMed Connect mobile accessory is not intended to replace the real-time display of continuous glucose monitor and/or insulin pump data on the primary display device (i.e., the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter.

The MiniMed Connect mobile accessory is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect mobile accessory is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect mobile accessory is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

mySentry™ Remote Glucose Monitor

Indications for Use

The mySentry system is indicated for the remote monitoring, within your home, of a single MiniMed® Paradigm REAL-Time Revel™ insulin pump (MMT-523/-723/MMT-523K/-723K).The REAL-Time glucose values provided by the monitor, as received from the MiniMed Paradigm REAL-Time Revel insulin pump, are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that may require a confirmation fingerstick measurement. All therapy adjustments should be based on measurements obtained using a blood glucose meter and not based on the value displayed by the monitor or MiniMed Paradigm REAL-Time Revel insulin pump.

Contraindications

None known.

Warnings/Precautions

The mySentry monitor only displays the information from the pump and is a way to monitor a pump wearer from another room. Once you turn off an alarm on the mySentry monitor, you need to attend to the alarm on the pump itself. You cannot respond to pump alarms directly through the mySentry monitor.

The mySentry system is not a replacement for personal blood glucose monitoring as directed by your physician. As such, it is very important that you continue your own personal blood glucose monitoring program. Failure to monitor your blood glucose independently of the real-time glucose values provided by the mySentry monitor, as received from the MiniMed Paradigm REAL-Time Revel insulin pump, may result in hyperglycemia or hypoglycemia and significant physical injury, including death.

Although the mySentry system has been designed and tested to meet or exceed the latest industry standards as required by the Food and Drug Administration (FDA), the mySentry system transmits/receives information wirelessly by radio frequency (RF) transmission (unencrypted) and therefore can be susceptible to RF or electrical interference, or possible interception. If there is RF interference or if the pump is out of range of the monitor, it will not transmit data. Take care to pay attention to the Historical vs. Real-Time Data icons for accurate interpretation of data. See Historical Data and Real-Time Data icons in the Basics chapter for more information.

Transmission of all data or alarms cannot be guaranteed with the mySentry system. This product does not provide any medical advice and should not be relied upon for such purpose. Please refer to the MiniMed Paradigm REAL-Time Revel insulin pump before making therapy decisions.